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Adds the veterinary sedative xylazine (including its salts and isomers) to Schedule III of the Controlled Substances Act and directs federal agencies to treat, regulate, and report on xylazine accordingly. The law limits which Schedule III requirements apply immediately to xylazine by providing short transition periods and clarifies that ordinary end users do not need to register to possess xylazine as described. Requires the U.S. Sentencing Commission to review penalties for xylazine-related crimes and directs the Attorney General (through DEA, coordinating with FDA) to deliver two congressionally mandated reports about xylazine prevalence, trafficking, and misuse (one within 18 months and an update within 4 years). It also includes unspecified targeted amendments to registration/authority provisions in the Controlled Substances Act to align administration with the new scheduling decision.
Amends Schedule III in section 202(c) of the Controlled Substances Act (21 U.S.C. 812) by adding a new subsection (f) that places any material, compound, mixture, or preparation containing any quantity of xylazine into Schedule III unless specifically excepted or listed in another schedule.
Amends subsection (i) of 21 U.S.C. 827 by inserting additional text in the matter preceding paragraph (1) and by inserting text into paragraph (6). The specific inserted text is not included in the provided section.
Strikes existing paragraph (27) of 21 U.S.C. 802 and inserts a new paragraph (27) that (A) defines 'ultimate user' generally and (B) adds a specific definition and inclusions for xylazine, including an exception for xylazine drug products approved under section 505(b) or (j) of the Federal Food, Drug, and Cosmetic Act and explicitly including government agencies or businesses where animals are located and employees or agents acting within the scope of their employment or agency.
Establishes that, for purposes of this title of the bill, the term “xylazine” has the meaning given in paragraph (60) of section 102 of the Controlled Substances Act, as added by this section.
Amends section 102 of the Controlled Substances Act (21 U.S.C. 802) by adding a new paragraph (60) that defines “xylazine” to mean the substance xylazine, including its salts, isomers, and salts of isomers whenever such salts, isomers, and salts of isomers are possible.
Amend Schedule III of section 202(c) of the Controlled Substances Act by adding a new subsection (f) stating: unless specifically excepted or listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of xylazine is included in Schedule III.
Amends Section 102 of the Controlled Substances Act (21 U.S.C. 802) by replacing paragraph (27) with a new definition of “ultimate user.” The general rule (subparagraph (A)) defines “ultimate user” as a person who lawfully obtained and possesses a controlled substance for their own use, for use by a household member, or for an animal owned by the person or household member. Subparagraph (B) creates a special rule for xylazine (except for FD&C Act-approved drug products under 21 U.S.C. 355(b) or (j)) that extends the “ultimate user” concept to include government agencies or businesses where animals are located and employees/agents of those entities acting within the scope of employment or agency.
Entities that manufacture xylazine as of the date of enactment are not required to make the capital expenditures needed to install the security standard that applies to Schedule III controlled substances for the purpose of manufacturing xylazine.
Who is affected and how:
People who use illicit drugs and people exposed to adulterated drug supplies: Scheduling xylazine aims to reduce uncontrolled distribution, but it may shift market behavior (substitution, changes in adulteration patterns). Public-health responders and harm‑reduction providers will need updated guidance because xylazine is not an opioid — naloxone may not reverse xylazine effects, complicating overdose response.
Health care providers, emergency departments, and harm‑reduction programs: Providers will face clinical and reporting implications around identifying and treating xylazine‑involved presentations. The law’s reporting requirements should improve surveillance data but may also require additional lab testing capacity and clinical protocols.
Law enforcement and prosecutors: Scheduling creates a federal framework for criminal enforcement against unauthorized manufacture, distribution, and trafficking of xylazine. The Sentencing Commission review will likely change guideline ranges and influence charging, plea bargaining, and sentencing practices.
Veterinarians, veterinary clinics, and animal-drug supply chains: Xylazine is used in veterinary medicine. The bill phases in some requirements and directs agencies to expedite manufacturer processes, but manufacturers, distributors, and veterinarians may still face new compliance burdens for procurement, storage, and recordkeeping after transition periods.
Pharmacies and distributors: Entities that handle substances for legitimate medical or veterinary use will need to conform to Schedule III controls once transition windows close; temporary relaxations for "ultimate users" do not eliminate later security, labeling, or registration obligations for suppliers.
Federal agencies and courts: DEA and FDA are directed to coordinate and accelerate administrative tasks tied to rescheduling; the Attorney General must produce two reports, and the Sentencing Commission must implement guideline review—these duties will require staff resources and interagency coordination.
Criminal-justice affected populations and courts: People prosecuted for offenses involving xylazine may see different guideline calculations after the Sentencing Commission acts, potentially increasing or clarifying penalties for trafficking and distribution offenses involving xylazine, particularly when it is used in combination with other scheduled drugs.
Net effect and tradeoffs:
Expand sections to see detailed analysis
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Introduced February 12, 2025 by James Varni Panetta · Last progress February 12, 2025
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Introduced in House